Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)
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|ClinicalTrials.gov Identifier: NCT00626717|
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 17, 2013
Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.
Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.
Methods: Randomised, placebo controlled, double blinded, multicenter trial.
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Procedure: Riboflavin/UVA crosslinking Procedure: Sham treatment||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Procedure: Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
|Sham Comparator: 2||
Procedure: Sham treatment
Fluorescein eye drops. Exposure with blue light
- Keratoconus progression [ Time Frame: 3 years ]
- Endothelial cell loss [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626717
|University Eye Hospital Freiburg|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Principal Investigator:||Philip Maier, MD||University Eye Hospital, Freiburg|